4.  For new screening technologies, approval by the Food and Drug Administration (FDA)  and coverage decisions by the Health Care Financing Administration (HCFA)  and private insurers should depend on evidence of improved clinical outcome.  This pursuit should be streamlined by coordinating oversight and support from all relevant participants (FDA, NCI, HCFA, private insurers, and breast cancer advocacy organizations) at a very early stage in the process. Such an approach should prevent technologies that have been approved for diagnostic use from being used prematurely for screening in the absence of evidence of benefit.  Technology sponsors generally lack the resources and incentive to undertake large, long-lasting, and expensive screening studies,  but a coordinated approach would make it easier to conduct clinical trials to gather the necessary outcome data. The proposed process should provide for the following:

•  FDA should approve new cancer detection technologies for diagnostic use in the traditional fashion, based on evidence of the accuracy (sensitivity and specificity) of new devices or tests in the diagnostic setting. In the case of “next-generation” devices (in which technical improvements have been made to a predicate device already on the market), technical advantages such as patient comfort or ease of data acquisition and storage could be considered in the determination of approval.

•  If a new device that has been approved for diagnostic use shows potential for use as a screening tool (based on evidence of accuracy) and the developers wish to pursue a screening use, an investigational device exemption should be granted for this use and conditional coverage should be provided for the purpose of conducting large-scale screening trials to assess clinical outcomes.

•  Trials should be designed and conducted with input from FDA, NCI, HCFA, the Agency for Healthcare Research and Quality, and breast cancer advocacy organizations. Informed consent acknowledging the specific risks of participating in a screening trial would be necessary.

•  HCFA and other payers should agree to conditionally cover the cost of performing the test in the approved clinical trials, whereas NCI and the technology’s sponsors should take responsibility for other trial expenses. Participation by private insurers would be particularly important for the assessment of new technologies intended for use in younger women who are not yet eligible for Medicare coverage.  Although this expense may initially seem burdensome to private insurers,  the cost of providing tests within a clinical trial would be much less than the costs associated with broad adoption by the public (and the associated pressure to provide coverage)  in the absence of experimental evidence for improved clinical outcome.

•  Trial data should be reviewed at appropriate intervals,  and the results should determine whether FDA approval should be granted (for those deemed sufficiently effective) and coverage should be extended to use outside of the trials. (A prior approval for diagnosis would remain in place regardless of the decision for screening applications.)

•  The ideal end point for clinical outcome is decreased disease-specific mortality. However, given the length of time required to assess that end point and the fact that early detection by screening mammography has already been proven to reduce breast cancer mortality,  a surrogate end point for breast cancer detection is appropriate in some cases. As a general rule, a screening technology that consistently detects early invasive breast cancer could be presumed efficacious for the purposes of FDA approval. Detection of premalignant or preinvasive breast lesions, however,  cannot be assumed to reduce breast cancer mortality or increase benefits to women, and it is not an appropriate surrogate end point for FDA approval, given the current lack of understanding of the biology of these lesions.

5. The National Cancer Institute should create a permanent infrastructure for testing the efficacy and clinical effectiveness of new technologies for early cancer detection as they emerge. The NCI Breast Cancer Surveillance Consortium and the American College of Radiology Imaging Network may provide novel platforms for this purpose through the creation of databases and archives of clinical samples from thousands of study participants.

6.  The Health Care Financing Administration should analyze the current Medicare and Medicaid reimbursement rates for mammography, including a comparison with other radiological techniques, to determine whether they adequately cover the total costs of providing the procedure. The cost analysis of mammography should include the costs associated with meeting the requirements of the Mammography Quality Standards Act.  A panel of external and independent experts should be involved in the analysis.

7.  The Health Resources and Services Administration (HRSA) should undertake or fund a study that analyzes trends in specialty training for breast cancer screening among radiologists and radiologic technologists and that examines the factors that affect practitioners’ decisions to enter or remain in the field. If the trend suggests an impending shortage of trained experts, HRSA should seek input from professional societies such as the American College of Radiology and the Society of Breast Imaging in making recommendations to reverse the trend.